Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)
Components of Participating Organizations
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)
National Cancer Institute (NCI),
(http://www.nci.nih.gov/)
National Human Genome Research Institute (NHGRI), (http://www.genome.gov/)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov/)
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov/)
(NIDDK not participating as of 11/9/2006, per NOT-DK-06-021)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidr.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)
National Library of Medicine (NLM),
(http://www.nlm.nih.gov/)
Title: Exploratory Innovations in Biomedical Computational
Science and Technology (R21)
Announcement Type
This is a reissue and
modification of PAR-03-106,
previously issued April 17, 2003. This FOA (PAR-06-411) supports only the R21
mechanism. The R01 component of this initiative can now be found under PAR-06-410.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Program Announcement (PA) Number: PAR-06-411
Key Dates (Revised per NOT-GM-07-114)
Release/Posted Date: May 15, 2006Key Dates (Original Dates – Superseded by Dates Above)
Release/Posted Date: May 15, 2006Additional
Overview Content
Executive Summary
The NIH is interested in promoting research and developments in computational science and technology that will support rapid progress in areas of scientific opportunity in biomedical research. As defined here, biomedical computing or biomedical information science and technology includes database design, graphical interfaces, querying approaches, data retrieval, data visualization and manipulation, data integration through the development of integrated analytical tools, and tools for electronic collaboration, as well as computational and mathematical research including the development of structural, functional, integrative, and analytical models and simulations.
Table of Contents
Part I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1.
Research Objectives
Section
II. Award Information
1.
Mechanism of Support
2. Funds
Available
Section
III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost
Sharing or Matching
3. Other
- Special Eligibility Criteria
Section
IV. Application and Submission Information
1.
Request Application Information
2.
Content and Form of Application Submission
3.
Submission Dates and Times
A. Submission, Review, and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4.
Intergovernmental Review
5.
Funding Restrictions
6. Other
Submission Requirements
Section
V. Application Review Information
1.
Criteria
2.
Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3.
Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award
Notices
2.
Administrative and National Policy Requirements
3.
Reporting
Section
VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer
Review Contact(s)
3.
Financial/Grants Management Contact(s)
Section VIII. Other Information - Required Federal
Citations
Part
II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Computing and
computational tools have become increasingly important in enabling progress in
biomedical research. In recognition of the critical role computing and computer
science plays in biomedical research, the NIH Director commissioned a Working
Group on Biomedical Computing in June 1999. The result of the deliberations of
the Working Group on Biomedical Computing was a report entitled "The
Biomedical Information Science and Technology Initiative (BISTI)" which
can be accessed at the following site: http://www.nih.gov/welcome/director/060399.htm.
A major recommendation of the BISTI is that the NIH should provide additional
resources and incentives for basic research to provide adequate support for
those who are inventing, refining, and applying the tools of biomedical
computing. The promotion of the interface of biomedical information science
and technology with biomedical research should result in new digital and
electronic tools that will have substantial impact on broad areas of biomedical
research.
The Institutes and Centers of the NIH acknowledge the wisdom of this recommendation and offer support through the current solicitation for fundamental research in biomedical information science and technology as well as for the development of new informatics, computational and mathematical tools and technologies. BISTI targets support for fundamental research in biomedical computing science and technology as well as the development and application of new biocomputing tools or technologies for a particular area(s) of scientific opportunity in biomedical research.
This particular FOA is intended to support exploratory biomedical informatics and computational biology research—applications should be innovative, with high risk/high impact in new areas that are lacking preliminary data or development. Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. In the latter case, investigators should consult the parallel announcement PAR-06-410 “Innovations in Biomedical Computing Science and Technology”. For example, long-term projects, or projects designed to increase knowledge in a well-established area will not be considered for R21 awards.
Programs may target one or multiple areas of biomedical computing that will enable progress in biomedical research. Examples of data types that could be considered include but are not limited to genomic sequences, biomedical images, qualitative descriptors for health and social science, remote sensing and geospatial images, and pathway data. Specific research areas solicited in informatics or computational science include but are not limited to research, development and application of:
Particular research activities related to the formalization of data-related concepts are appropriate under this announcement. An overall goal of this announcement is to support research and development of tools and approaches for computing on data; most of these will likely be implemented in software. Best practices for such endeavors include the explicit formalization of data-related concepts that pertain directly to the software. This would include activities such as: 1) assessing data flow and use; 2) defining the terms used for data, fields, operations, etc.; 3) defining the relationships among terms and functions; 4) defining data models and schemas; and 5) other similar activities. It is important to emphasize that these activities are appropriate as they relate closely to the particular software itself, or to making the particular software interoperable with other specific software or computational resources.
Areas of biomedical research likely to be critically dependent on biocomputing advances include but are not limited to:
Projects must span the interface of biomedical research and biomedical computational science and technology. Applicants will be expected to demonstrate fundamental understanding and adequate expertise in both the relevant areas of computational science and technology and biomedical research. Cross-disciplinary collaborations are strongly encouraged, including those exploratory or high risk/high impact grant applications which have been initiated or fostered through other cross-cutting initiatives, and now are seeking independent support.
Given the expanding needs in biomedical research for advances in a variety of areas of information science and technology, the approaches and technologies proposed under this announcement should ultimately be generalizable, scalable, extensible, and interoperable. The projects should take into account the needs of the biomedical research community that will be the ultimate end users of the products of the research. The projects should also address plans for ensuring the dissemination of useful products of the research, including approaches, technologies and tools, to the relevant research and user communities. The informatics and computational research proposed should be future-oriented, fill an area of need or projected need, and seek to exceed the current state of the art.
Some NIH institutes and centers may have other grant mechanisms that could apply to biomedical computing projects. Interested participants should contact the institute or center technical contact indicated in the "List of BISTI Contacts" located at the URL given in the INQUIRIES section of the announcement.
Through separate program announcements, the participating Institutes and Centers of the NIH invite applications for SBIR and STTR support focusing on the similar research areas as described in the RESEARCH OBJECTIVES section of this solicitation. Applicants are encouraged to visit the BISTI web site for SBIR/STTR and other relevant funding opportunities http://www.bisti.nih.gov/bistic_funding.cfm.
See Section VIII, Other Information
- Required Federal Citations, for policies related to this
announcement.
Section
II. Award Information
1. Mechanism of Support
This FOA will use the NIH Exploratory/Developmental Research Grant (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project (http://grants.nih.gov/grants/funding/r21.htm).
This FOA uses just-in-time concepts. It also uses the modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).
Exploratory/developmental grant support is for new projects only; competing renewal (formerly “competing continuation”) applications will not be accepted. Up to two resubmissions (formerly “revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003.
2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, applications must stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this Program Announcement funding opportunity.
F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.
Section III. Eligibility Information
1. Eligible Applicants
1.A.
Eligible Institutions
You
may submit an application(s) if your organization has any of the following
characteristics:
1.B. Eligible Individuals
Any individual
with the skills, knowledge, and resources necessary to carry out the proposed
research as the Project Director/Principal Investigator (PD/PI) is invited to
work with his/her organization to develop an application for support.
Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH support.
2. Cost Sharing or Matching
This program does not
require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Not
applicable
Section
IV. Application and Submission Information
To download a SF424 (R&R) Application Package and
SF424 (R&R) SBIR/STTR Application Guide for completing the SF424 (R&R)
forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants must
download the SF424 (R&R) application forms and SF424 (R&R) Application
Guide for this FOA through Grants.gov/Apply.
Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.
For further assistance, contact GrantsInfo: Telephone
301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY
301-451-0088.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424
(R&R) (Cover component)
Research & Related Project/Performance Site
Locations
Research
& Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget
Optional
Components:
PHS398 Cover
Letter File
Research & Related Subaward Budget Attachment(s)
Form
Note: While both budget components are included in the SF424
(R&R) forms package, the NIH R21 uses ONLY the PHS398 Modular Budget. (Do not use the detailed Research & Related Budget.)
Foreign Organizations
Several special provisions apply to applications
submitted by foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: May 15, 2006 (Earliest date an
application may be submitted to Grants.gov)
Application Submission/Receipt
Date(s): June
24, 2006; September 24, 2006; January 24, 2007; May 24, 2007; September 24,
2007; January 24, 2008; May 24, 2008; September 24, 2008
January
24, 2009
Peer Review Date(s): October-November 2006; February-March
2007; June-July 2007; October-November 2007; February-March, 2008; June-July
2008; October-November, 2008; February-March, 2009; June-July, 2009
Council Review Date(s): January-February, 2007; May-June,
2007; September-October, 2007; January-February, 2008; May-June, 2008;
September-October, 2008; January-February, 2009; May-June, 2009;
September-October, 2009
Earliest Anticipated
Start Date(s): April,
2007; July, 2007; December 2007; April, 2008; July, 2008; December, 2008;
April, 2009; July 2009, December, 2009
3.A.1.
Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Sending an Application to the NIH
To submit an
application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow
steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE
ACCEPTED.
3.C. Application
Processing
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt,
applications will be evaluated for completeness by the Center for Scientific
Review, NIH. Incomplete applications will not be reviewed.
There will be
an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the
Commons.
The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the terms and
conditions, cost principles, and other considerations described in the NIH Grants
Policy Statement.
Pre-Award
Costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new award if such
costs: are necessary to conduct the project, and would be allowable under the
grant, if awarded, without NIH prior approval. If specific expenditures would
otherwise require prior approval, the grantee must obtain NIH approval before
incurring the cost. NIH prior approval is required for any costs to be incurred
more than 90 days before the beginning date of the initial budget period of a
new award.
The incurrence of
pre-award costs in anticipation of a competing or non-competing award imposes
no obligation on NIH either to make the award or to increase the amount of the
approved budget if an award is made for less than the amount anticipated and is
inadequate to cover the pre-award costs incurred. NIH expects the grantee to be
fully aware that pre-award costs result in borrowing against future support and
that such borrowing must not impair the grantee's ability to accomplish the
project objectives in the approved time frame or in any way adversely affect
the conduct of the project. See the NIH
Grants Policy Statement.
6. Other Submission Requirements
The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”
Renewal (formerly “competing continuation” or “Type 2”) applications are not permitted.
All application instructions outlined in the SF424 (R&R) application are to be followed, with the following requirements for R21 applications:
Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Do not use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe these limitations may be delayed in the review process.
Plan for Sharing Research Data
The
precise content of the data-sharing plan will vary, depending on the data being
collected and how the investigator is planning to share the data. Applicants
who are planning to share data may wish to describe briefly the expected
schedule for data sharing, the format of the final dataset, the documentation to
be provided, whether or not any analytic tools also will be provided, whether
or not a data-sharing agreement will be required and, if so, a brief
description of such an agreement (including the criteria for deciding who can
receive the data and whether or not any conditions will be placed on their
use), and the mode of data sharing (e.g., under their own auspices by mailing a
disk or posting data on their institutional or personal website, through a data
archive or enclave). Investigators choosing to share under their own auspices
may wish to enter into a data-sharing agreement. References to data sharing may
also be appropriate in other sections of the application.
All
applicants must include a plan for sharing research data in their application.
The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.
The
reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Sharing Research Resources
NIH policy requires that grant awardee recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (NIH Grants Policy
Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the
resources sharing plan and any related data sharing plans will be considered by
Program staff of the funding organization when making recommendations about
funding applications. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590). See Section VI.3., “Reporting.”
Plan for Sharing Software
A software dissemination plan, with appropriate timelines, must be included in the application. This should be included in a separate heading in the Research Design and Methods section. There is no prescribed single license for software produced through grants responding to this announcement. However, NIH does have goals for software dissemination, and reviewers will be instructed to evaluate the dissemination plan relative to these goals:
1. The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
2. The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
3. To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
4. The terms of software availability should include the ability of researchers to modify the source code and to share modifications with other colleagues. An applicant should take responsibility for creating the original and subsequent “official” versions of a piece of software, and should provide a plan to manage the dissemination or adoption of improvements or customizations of that software by others. This plan should include a method to distribute other user's contributions such as extensions, compatible modules, or plug-ins.
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.
Applications that are complete will be evaluated for scientific and technical merit by an appropriate review groups convened by the Center for Scientific Review (CSR) in accordance with the review criteria stated below.
As
part of the initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The NIH R21 grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research. Because the Research Plan is limited to 15 pages, an R21 grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
Innovation: Is the project original and innovative? For example: Does
the project challenge existing paradigms or clinical practice; address an
innovative hypothesis or critical barrier to progress in the field? Does the
project develop or employ novel concepts, approaches, methodologies, tools, or
technologies for this area?
Investigators: Are the investigators appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the PD/PI and other researchers? Does the investigative team bring
complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed studies benefit
from unique features of the scientific environment, or subject populations, or
employ useful collaborative arrangements? Is there evidence of institutional
support?
2.A. Additional Review Criteria:
In addition to the above criteria, the following items
will continue to be considered in the determination of scientific merit and the
priority score:
Protection of
Human Subjects from Research Risk: The involvement of human subjects
and protections from research risk relating to their participation in the
proposed research will be assessed. See item 6 of the Research Plan component
of the SF424 (R&R).
Inclusion of Women, Minorities and
Children in Research: The adequacy of plans to include
subjects from both genders, all racial and ethnic groups (and subgroups), and
children as appropriate for the scientific goals of the research will be
assessed. Plans for the recruitment and retention of subjects will also be
evaluated. See item 7 of the Research Plan component of the SF424 (R&R).
Care and Use
of Vertebrate Animals in Research: If vertebrate animals are to be
used in the project, the five items described under item 11 of the Research
Plan component of the SF424 (R&R) will be assessed.
Biohazards: If
materials or procedures are proposed that are potentially hazardous to research
personnel and/or the environment, determine if the proposed protection is
adequate.
2.B. Additional
Review Considerations
Budget
and Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. Is the effort listed for the PD/PI
appropriate for the work proposed? Is each budget category realistic and
justified in terms of the aims and methods?
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The presence of a data sharing plan will be part of the terms and conditions of
the award. The funding organization will be responsible for monitoring the data
sharing policy.
2.D. Sharing
Research Resources
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.
Program staff will be responsible for the administrative review of the plan for sharing research resources.
The
adequacy of the resources sharing plan and any related data sharing plans will
be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
“Reporting.”
The initial review group will comment on
the appropriateness of the proposed plans for sharing research data, research
resources, and software. However, they will not factor
the plans into the determination of the scientific merit or the priority score. The
adequacy of the software sharing plans will be considered by Program staff when
making recommendations about funding applications. In making such
considerations, prior to funding, program staff may request written statements
from the officials responsible for intellectual property issues at all of the
applicant institutions (including sub-contractors), to the effect that the
institution supports and agrees to abide by the software dissemination plans
put forth in the application. These letters must be clear expressions of
commitment. Program staff may negotiate modifications of the
software sharing plans with the Principal Investigator before recommending
funding of an application. The final version of the software sharing plans
negotiated by both will become a condition of the award of the grant. The
effectiveness of software sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report. (PHS 2590).
See Section
VI.3. Reporting
3. Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
After
the peer review of the application is completed, the PD/PI will be able to
access his or her Summary Statement (written critique) via the NIH eRA Commons.
If
the application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions
of NIH Grant Awards, Subpart A: General.
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section
IV.5., “Funding Restrictions.”
2. Administrative and National
Policy Requirements
All
NIH grant and cooperative agreement awards include the NIH Grants Policy
Statement as part of the NoA. For these terms of award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part II:
Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for
Specific Types of Grants, Grantees, and Activities.
3. Reporting
Awardees will be
required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
Section VII. Agency Contacts
We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:
1. Scientific/Research Contacts:
Please direct Institute- or domain-specific issues should be directed to the NIH BISTI contacts listed at the following Web site: http://www.bisti.nih.gov/R01-contacts.cfm.
Direct general questions regarding programmatic issues to:
Peter Lyster, Ph.D.
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences
45 Center Drive, Room 2AS.55k, MSC 6200
Bethesda, MD 20892-6200
TEL:
301-451-6446
Email: lysterp@mail.nih.gov
2. Peer Review Contacts:
Direct your questions about peer review issues to:
Sally Amero, Ph.D.
Chief, Bioengineering Sciences and Technology IRG
Center for Scientific Review
6701 Rockledge Drive, Room 4190, MSC 7826
Bethesda, MD 20892-7826
Telephone: (301) 435-1159
FAX: 301-480-4042
Email: ameros@csr.nih.gov
3. Financial or Grants Management Contacts:
Direct your questions
about financial or grants management issues to:
Antoinette Holland
Grants Administration Branch
National Institute of General Medical Sciences
45 Center Drive, Room 2AN 50B, MSC 6200
Bethesda, MD 20892-6200
Phone: (301) 594-5132
Fax: (301) 480-2554
email: hollanda@nigms.nih.gov
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients
of PHS support for activities involving live, vertebrate animals must comply
with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal
regulations (45 CFR 46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data
and safety monitoring is required for all types of clinical trials, including
physiologic toxicity and dose-finding studies (phase I); efficacy studies
(Phase II); efficacy, effectiveness and comparative trials (Phase III).
Monitoring should be commensurate with risk. The establishment of data and
safety monitoring boards (DSMBs) is required for multi-site clinical trials
involving interventions that entail potential risks to the participants (“NIH
Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Access to Research Data through the Freedom of Information Act:
The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide access to research data through the Freedom of Information Act (FOIA)
under some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is important
for applicants to understand the basic scope of this amendment. NIH has
provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model Organisms:
NIH
is committed to support efforts that encourage sharing of important research
resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants
Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It
is the policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects or
the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing
clinical research should read the "NIH Guidelines for Inclusion of Women
and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The
NIH maintains a policy that children (i.e., individuals under the age of 21)
must be included in all clinical research, conducted or supported by the NIH,
unless there are scientific and ethical reasons not to include them.
All
investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH applications for research involving human
subjects and individuals designated as key personnel. The policy is available
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria
for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded
investigators are requested to submit to the NIH manuscript submission (NIHMS)
system (http://www.nihms.nih.gov) at
PubMed Central (PMC) an electronic version of the author's final manuscript upon
acceptance for publication, resulting from research supported in whole or in
part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH
is requesting that authors submit manuscripts resulting from 1) currently
funded NIH research projects or 2) previously supported NIH research projects
if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award
mechanisms, cooperative agreements, contracts, Institutional and Individual
Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.
For
more information about the Policy or the submission process, please visit the
NIH Public Access Policy Web site at http://publicaccess.nih.gov/
and view the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable Health Information:
The
Department of Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).
Decisions
about applicability and implementation of the Privacy Rule reside with the
researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and a set
of decision tools on "Am I a covered entity?" Information on the
impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All
applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information necessary
to the review because reviewers are under no obligation to view the Internet
sites. Furthermore, we caution reviewers that their anonymity may be
compromised when they directly access an Internet site.
Healthy People 2010:
The
Public Health Service (PHS) is committed to achieving the health promotion and
disease prevention objectives of "Healthy People 2010," a PHS-led
national activity for setting priority areas. This PA is related to one or more
of the priority areas. Potential applicants may obtain a copy of "Healthy
People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is
described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health Systems
Agency review. Awards are made under the authorization of Sections 301 and 405
of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants
Policy Statement.
The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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